FoxO3a and PU.1 in Acute Lymphoblastic Leukemia
Value of FoxO3a and PU.1 Expression in Pediatric Acute Lymphoblastic Leukemia
1 other identifier
observational
53
0 countries
N/A
Brief Summary
Acute Lymphoblastic Leukemia (ALL) is one of the four major types of leukemia which is common in both children and adolescents; however, it is the most common pediatric malignancy diagnosed in children younger than 20 years .The disease pathogenesis results from blockade at any stages of normal lymphoid differentiation with uncontrolled proliferation of lymphoid cells. According to the World Health Organization (WHO) definition, ALL is categorized in B-Lymphoblastic Leukemia (B-ALL) And T-Lymphoblastic Leukemia (T-ALL), originated from B- and T-Lineage lymphoid precursor cells, respectively.
Trial Health
Trial Health Score
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participants targeted
Target at P25-P50 for all trials
Started Aug 2023
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 14, 2019
CompletedFirst Posted
Study publicly available on registry
September 17, 2019
CompletedStudy Start
First participant enrolled
August 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2024
CompletedFebruary 8, 2023
February 1, 2023
8 months
September 14, 2019
February 5, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
FoxO3a and PU.1 levels in acute lymphoblastic leukemia
detection of the mean difference in FoxO3a and PU.1 expression levels between cases and controls
2 years
Study Arms (2)
study group
children aged 2-17 years and diagnosed as new cases of acute lymphoblastic leukemia
control group
healthy age- and sex-matched children without ahistory of any malignancies
Interventions
1. total RNA is isolated from fresh blood samples 2. RNA is converted into complementary DNA c.DNA 3. cDNA is then analysed by quantitatine Real Time PCR(qRT-PCR) to evaluate the relative expression levels of FoxO3a, PU.1 genes and TATA-binding protein (TBP) ,as an endogenous control gene.
Eligibility Criteria
* cases 1. inclusion criteria: children aged 2-17 years and diagnosed as new cases of acute lymphoblastic leukemia 2. exclusion criteria: 1. age more than 17 years 2. presence of other hematological disorders, history of other malignancies ,or relapsed ALL 3. patients under chemotherapy or radiotherapy * controls (healthy age- and sex-matched children without ahistory of any malignancies)
You may qualify if:
- children aged 2-17 years and diagnosed as new cases of acute lymphoblastic leukemia
You may not qualify if:
- age more than 17 years
- presence of other hematological disorders, history of other malignancies ,or relapsed ALL
- patients under chemotherapy or radiotherapy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (9)
Ferber EC, Peck B, Delpuech O, Bell GP, East P, Schulze A. FOXO3a regulates reactive oxygen metabolism by inhibiting mitochondrial gene expression. Cell Death Differ. 2012 Jun;19(6):968-79. doi: 10.1038/cdd.2011.179. Epub 2011 Dec 2.
PMID: 22139133BACKGROUNDInaba H, Greaves M, Mullighan CG. Acute lymphoblastic leukaemia. Lancet. 2013 Jun 1;381(9881):1943-55. doi: 10.1016/S0140-6736(12)62187-4. Epub 2013 Mar 22.
PMID: 23523389BACKGROUNDKerdiles YM, Beisner DR, Tinoco R, Dejean AS, Castrillon DH, DePinho RA, Hedrick SM. Foxo1 links homing and survival of naive T cells by regulating L-selectin, CCR7 and interleukin 7 receptor. Nat Immunol. 2009 Feb;10(2):176-84. doi: 10.1038/ni.1689. Epub 2009 Jan 11.
PMID: 19136962BACKGROUNDPui CH. Acute lymphoblastic leukemia: introduction. Semin Hematol. 2009 Jan;46(1):1-2. doi: 10.1053/j.seminhematol.2008.09.011. No abstract available.
PMID: 19100362BACKGROUNDXie Y, Davies SM, Xiang Y, Robison LL, Ross JA. Trends in leukemia incidence and survival in the United States (1973-1998). Cancer. 2003 May 1;97(9):2229-35. doi: 10.1002/cncr.11316.
PMID: 12712476BACKGROUNDYang XB, Zhao JJ, Huang CY, Wang QJ, Pan K, Wang DD, Pan QZ, Jiang SS, Lv L, Gao X, Chen HW, Yao JY, Zhi M, Xia JC. Decreased expression of the FOXO3a gene is associated with poor prognosis in primary gastric adenocarcinoma patients. PLoS One. 2013 Oct 23;8(10):e78158. doi: 10.1371/journal.pone.0078158. eCollection 2013.
PMID: 24194912BACKGROUNDZhang X, Tang N, Hadden TJ, Rishi AK. Akt, FoxO and regulation of apoptosis. Biochim Biophys Acta. 2011 Nov;1813(11):1978-86. doi: 10.1016/j.bbamcr.2011.03.010. Epub 2011 Mar 31.
PMID: 21440011BACKGROUNDAusserlechner MJ, Salvador C, Deutschmann A, Bodner M, Viola G, Bortolozzi R, Basso G, Hagenbuchner J, Obexer P. Therapy-resistant acute lymphoblastic leukemia (ALL) cells inactivate FOXO3 to escape apoptosis induction by TRAIL and Noxa. Oncotarget. 2013 Jul;4(7):995-1007. doi: 10.18632/oncotarget.953.
PMID: 23828551RESULTChiaretti S, Zini G, Bassan R. Diagnosis and subclassification of acute lymphoblastic leukemia. Mediterr J Hematol Infect Dis. 2014 Nov 1;6(1):e2014073. doi: 10.4084/MJHID.2014.073. eCollection 2014.
PMID: 25408859RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- principal investigator
Study Record Dates
First Submitted
September 14, 2019
First Posted
September 17, 2019
Study Start
August 1, 2023
Primary Completion
March 30, 2024
Study Completion
December 30, 2024
Last Updated
February 8, 2023
Record last verified: 2023-02